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How to Kill your surgical robot: Launch failures incoming

With the ever increasing march to surgical robotics - many companies big and small are either launching robots - or preparing to launch robots. Not only are they taking on Intuitive but they are taking on the market and the market demands.


Most strategies, robot designs, and feature sets were drawn up a decade ago (Yes it takes that long). Any plans and features that were made back then will most likely not hold today. And that’s a problem.



Surgical Robot disaster
Surgical Robot disaster


The big problem is the launch of da Vinci 5 which has just redefined the boundaries between the robot and the OR. And the fact that they achieved the almost impossible of getting a broad clearance with FDA.

So this article assumes Intuitive will launch the da Vinci 5 right - they actually know what they are doing. I'm talking to the rest of you.


As someone that led the launch of a surgical robot - and took it to the number two position after Intuitive - I learned a few things. Here my list of things that will potentially kill your launch and make your market entry almost impossible. I could be wrong… and maybe you know better.



Be late with your surgical robot

The clock is now ticking with da Vinci 5. It was announced just a few weeks ago - and already surgeon after surgeon are posting reviews across linked in of their “Hands on.” Intuitive are not hanging around - and although they announced a slow roll out. That doesn’t mean they aren’t doing a full on market awareness campaign. It’s everywhere.


Every single day you are not in a “Relevant” market or a “taste maker” market - you are losing ground in the fight.

If you are not in the USA within the next 12 months, your relevance is dwindling day by day.


You need to be cleared in the USA in 2024 or 2025 at the very very latest. If not, the march of Intuitive will have made the barrier to entry even higher than it is today. Everyone will be within their formidable ecosystem - and they won’t be switching to your lower functionality robot. And that lower functionality will be - just by regulatory barriers alone. Forget the technical abilities of your team.


If you don’t get on the market soon - then give up and go home. You will save more money.

If you’re not on the US market soon - think about leaving that beast alone.


The “Yeah but coming last means we are learning from everyone’s mistakes” is internal speak to justify why you’re late. No, you don’t learn from others mistakes - because those mistakes have a 6 month relevancy in surgical robotics.


The competition is evolving - the change over of procedures is evolving - techniques are evolving and supporting data ecosystems are evolving. All on a cycle you have never seen before.


And most of the mistakes that really will kill you are made behind closed doors - and not made public.


If you or your company is not considered a “contender” in at least two or three core markets.

You are done in general surgery and thoracic surgery.


If your company is a “big company” - and you don’t have a robot in this space… with relevance - go buy one — today! Go get an asset on the market that you can build on. Buy relevance now.



Wrong assumptions

When you all sat around the table some 3 to 5 years ago - or maybe even a decade ago - you will have sat and looked at the market 3-5 years ago or a decade ago. You will have been comparing a lot of the world and numbers to the impact of the da Vinci Si, and will then have moved to understand how the market felt about the Xi.


As per my “8 Misconceptions about surgical robotics”  (read it here ) there could have been lots of group think around that table.

“People can’t wait to run from Intuitive.”

“They can have urology - we’ll have bariatrics and thoracics - where we are leaders there.”

“Accounts are wanting us to come and compete. Our friends tell us every day.”

“We will crash the price of a procedure and finally democratise robotic surgery.”

“We are only 5% penetrated into robotics. It’s still early.”


Whatever assumptions you were basing your feature set, marketing strategy, USP on - well things have moved on. In procedures that people actually care about, in markets people actually care about - just go read the latest papers that analysed penetration and trends.

Intuitive dominate in colorectal surgery, gynaecological surgery, upper Gi… oh and yeah - urology.


If you ,in any way, are still thinking that customers (in the USA especially) are just dying for you to come onto the market so they can run into your arms and abandon those terrible Intuitive folk - you are delusional.


Base your model on selling hardware

Jamie from Intuitive was clear. 70% of their installs were lease style deals in the last months. As per my article (read it here) on Intuitive moving to a service model. You will not be selling million dollar hardware to line your pockets and get a large cash lump sum up front. No!


Those days are gone, and you missed that boat. So for the smart companies that are already building smaller - lighter - less capital intensive robots - well done.


For the main frame companies - you better be prepared to carry all those systems on your books.

Let’s say you plan 100, 200, 300, 400 systems after launch (year 1 to 4) — oh and you’re dreaming by the way. If your excel sheet looks like that - start getting a dose of reality.


But let’s say you could (I’m smiling) - and each system will cost you $500K fully loaded COGS.

You are going to need to finance 1000 systems - that’s $500 million of COGS out the door - so you better be getting high end - expensive instruments creating revenue - service - and have 20 lives on your basic instruments or this will be a money pit from hell. Forget all the costs of more training - more spare parts - demo systems - commercial teams - implementation teams (yep you will need 2 or 3 people per system to keep it going in the first year at least.) Those 10:1 ratios you’ve all modelled… forget it.


The margins in the first few years - all negative.

The instruments will cripple you.

The lack of clearance on your staplers and advanced energy will hurt you.


It’s a service model. Make sure you sell, to a service model. Oh and that means you won’t be making those “fantasy” 30% cheaper than da Vinci savings you’re been promising everyone. The maths doesn’t add up.


Pick USA as first launch market

Suicidal or stupid? You choose.

The last place on earth you want to place a robot that will have software bugs, instrument failures, user issues, imaging issues, low feature sets, teams trying to work out how to implement, training programs that are not 100% polished - is the least forgiving market - the market that is home to Intuitive - the market that has the world’s best experience with robotics - the coin operated market - the taste maker market…


Any company that is arrogant enough to think they should go to the USA with their new robot - first (before they work all their shit out) deserves to fail.


If you fail in the USA - have field corrective actions - or a recall. Then that will be very public and very costly. Be smart - go find a market that is meaningful but not catastrophic if you get it wrong.


Do not launch first into the USA !!!!


Limited surgical procedures

Part of the problem with the USA will be that you will have - by the nature of FDA - a limited number of procedures you can actually do.

A robot that can do two or three procedures is not a business.

Let me repeat that - if you can do only two or three procedures - you don’t have a commercial product.

You do have a curious “new system” for people to try and then write papers on. But you won’t be getting to the volume of systems to be a sustainable business any time soon.


In some markets the limited procedures is okay - you can find a department that is willing to do some low volumes of procedures - get one or two users that will be enthusiasts. Places where “cash is not king.”


In the USA that model will not work. In Australia you will struggle. In other markets that have certain health care system - limited procedures = limited sales.


Oh you can give it to your friends - but that is not a business.


Da Vinci 5 - is broadly cleared in the USA. Tomorrow they can replace any Xi and continue operating as if nothing changed. Small training delta  in hospital - that’s it.

Instead - if your system has two procedures - what does a hospital do? It stops doing the other ten procedures for the privilege of using your nixed robot? No.


“But the hospital has capacity constraints… they need a system just for this specialty.”


Erm - and if they need some other specialty to use it due to those very capacity constraints? Why would they not just get over the capacity constraints with another Xi or DV5. Which is already known across all users - requires no further training etc etc etc.


Launch in the USA when you have a critical mass of procedures  -if you are a mainframe.

If you’re a Vicarious Surgical - you can offer something “so different” that you can get away with being in a niche of procedures - as the comparator is NOT da Vinci in a direct head to head.

Understand the Xi is a “workhorse” you must replace a work horse with a work horse!


If you are beating your chest - saying “We know what the market needs.”

“We are building a next generation robot up from da Vinci.”

“We are bringing something so new and amazing.”

“We are building a da Vinci killer.”


It better be so fucking good - do more procedures - bring way better value - bring massive OR efficiencies. Or why the hell would any “commercial” deal pick you?


Get to procedural critical mass before stepping a toe into the USA - or be a research curiosity.



Wrong surgical procedures

Having just a few surgical procedures is bad enough - but what if you have no understanding of how the surgical robotics world works - and you then pick the wrong surgical procedures to go after first. This isn’t about surgical procedures - it’s about robotics politics.


The most obvious mistake is ignoring Urology.


“But da Vinci is the urology robot… we definitely won’t get cleared in prostates - it’s not our customer base.”


Oh dear! That means you know little about the way surgical robots are bought across the world.

Your one strong general surgeon doesn’t get to decide alone if they adopt a robot.


If you don’t know what RUG means - I’m not telling you. But you don’t deserve to be making any decisions about robotic strategy. In many places the RUG decides - period.

Who is the first person the RUG asks? The urologist. Who often leads the RUG.


Urologist that leads the RUG - “So tell me about your new robot you’re proposing. Does it do prostates?”


You “No.”


Urologist - “Ah so we have to buy this robot on top of the other robot?”


You “No we’re a da Vinci killer you just need us and we’ll discount our other products that you don’t use. We don’t care about urologists that much. Go play with da Vinci.”


Urologist - “So if we upgrade our current robot, I need to stop doing prostates?”


You “Yes - we’ll come back to you when we eventually get around to that.”


Urologist to their assistant - “Taxi for one please.”


If you do not get urology as a first approval in the USA , or a lot of markets - you will struggle.

And if you think - yes but we will go to other departments - you are now forcing them to go multi robot system. It’s of course possible - but you just made it 100X harder for your commercial teams to have meaningful conversations with hospitals.

You have alienated a group of key robotics decision makers that you are probably not already deep friends with their community. You don’t understand the power of the urologist in the purchasing decision.

Where as - intuitive does.

(It doesn’t matter if this is not for urology - the urologist will be asked if it’s valid as a technology.)


The next big wrong thing could be. “Let’s get two or three procedures that we are strong in today. Let’s go to our community. Let’s go where we sell lots of staplers, or imaging today and have lots of advanced energy or advanced imaging!”


So let me get this straight. You’re going to go to say... Thoracic and bariatric and Colorectal - some of the toughest procedures for a fledgling robot to work in.

In thoracic - if the system has an issue - and it will - you will have a blocked robot in the chest!

If your energy delivery is bad - you will get bleeding in the chest and need emergency conversion to open.

You will go to a community that is screaming for console operated staplers - and moving to intuitive by the dozen to use their Sureform.


And you turn up with an “experimental” robot with no stapler - and no advanced energy on it.

And that is the first place you want to go and fight?


Or Bariatric - where it is known that the robot brings little to no real value. Where reach - arm strength and access will test your robot to the utter limits - and where time is money.


And you turn up with your young robot with no stapler or advanced energy; and want them to scrub up - set the robot up - scrub out - use the robot - scrub up to apply advanced energy - scrub out - scrub up fire the staplers - scrub out finish the case.


Or colorectal - where they use advanced energy all day long - advanced imaging (ICG) - multi quadrant - needing staplers.


That might all work if you are in a market that has lots of qualified bedside assistants - it ain’t working in a busy hospital in the USA.


You need surgical procedures that are tried and tested - prostates - hernia - upper GI hiatal work.

Things where the wristed needle driver is an utter must and the benefits of the robot shine. Not procedures that defend your stapling or energy products - or worse -  you believe they avoid Intuitive.

Intuitive is in certain procedures because the robot brings the most benefit - and you want to avoid them?

Besides that Intuitive is in every abdominal and thoracic procedure ! How will you avoid them?


Good luck with that.



Have the wrong team sell your product

If there’s one thing I learned the hard way… it’s that selling a surgical robot is like nothing in medical devices.

“But I’ve sold camera towers!” - don’t make me laugh.

You are selling a 7 years surgical program - change of service - change of way of working that involves all surgical departments, IT, sterilisation, the entire C-suite of the hospital, purchasers, nursing teams, Biomedical engineering and more.


It’s software - hardware - robotics - imaging systems - disposables - instruments - resposables - complete reusables - accessories and apps.


If anyone thinks they can sell a surgical robot along side a suture - they need their head feeling.

If you think you can put this alongside selling endoscopy products - wow.


This is a stand alone segment on its own. It’s not a spine robot - (one specialty) - it’s not an imaging system (that’s a tiny part of it) - it’s not a stapler (commodity) - it’s not like anything else.


Your team will need to know the inside of the OR like nothing on earth - be there for every case. Every specialty - every procedure - every instrument needs in every procedure. How to debug a system - how to sterilise the product - logistics - servicing - the list goes on.


Think you have a turnkey commercial force today that can “drop the product in”. Go to another sector - you don’t understand soft tissue surgical robotics.



Think your product will work

Your product will not work properly for two years. In the eyes of a hardcore da Vinci user - it will suck!

You will have tons of software bugs - your imaging system will have glitches - you will have alarms and stops and faults. Your joints will get backlash - your buttons will stick. Your connectors will have issues. You will have service engineers stripping it down night and day.

Your instruments will survive one or two lives - then break. You will have cleaning issues - you will have electrosurgery failures. You will have haptic controller failures - the list goes on.


It’s okay - it has happened to the best of everyone. So if you think “yes but we know best” and believe that your system will work out of the box in a clinical environment as well as it worked on those 100 lab cadavers in that controlled environment on hand built systems surrounded by engineers. Be prepared for some very agitated meetings - some sleepless nights - and a lot of remedial work.


The hardest thing about a robot is “every damned thing.” (Luke Hares)

I’m watching several companies from the side lines that are struggling - day in day out - and basically throwing bodies - money and human resources at it to get it over those teething troubles.


Launch in Japan - the USA - Australia and have these problems - and be prepared for systems coming back.


Your product will NOT work out of the box - accept it - prepare for it - make a launch strategy with hospitals that will “understand” and surgeons that won’t throw you under the Intuitive bus.



No robotic staplers

Tenders - Tenders - Tenders.

No stapler? No tender.

Today you can edge around it by saying “But that will only be Intuitive that can provide that.”

Tomorrow it will be “But that’s only Intuitive and Medtronic that can provide that”

Then add JNJ.


In tenders within 5 years… you will need a stapler for most specialties.


In the USA - console fired staplers in robotics for certain cases are an absolute must. (Thoracic)

If not there is the scrub in scrub out dance. Or you need to pay for an assistant that is legally allowed to fire the stapler.


But once a surgeon controls and fires a stapler from the console - there is no going back - none.



Launch into the USA without a stapler - you’re asking for trouble.

Launch into certain specialties without a stapler - you’re asking for trouble.

Go after GPOs and Tenders within 5 years without a stapler… rinse and repeat.



No robotic advanced energy

For the stapler you could be forgiven. You could have that moment in the surgery where an assistant can “fire the stapler” - perhaps. Or the surgeon is willing ti scrub in. Perhaps. It’s a snapshot in time of the case.


Advanced energy usage is constant and only acceptable from the console.

You can justify all the shit you want that “well with monpolar and bipolar they can do just as much.”

Yes - but it takes longer - takes more skill and people love Ligasure and Ultracsion. Period.

Colorectal, thoracic, upper GI, Hepatobiliary, and some Gyn want advanced energy. They feel it’s faster and safer.


Again this is now becoming a table stake in tenders across the world. I’ve seen it.

5 years ago - you could get away with it. Not today. And not tomorrow. Don’t look at systems that launched 5 years ago and had success. The world moved on. Expectations have changed.


And as better wristed energy devices come - the benefits of the 3D vision combined with wristing - combined with advanced energy (multifunction) - will all stack up to a must have.


Launch without advanced energy and you will not get broad adoption.


No Advanced imaging (ICG)

ICG is already now a gold standard in many procedures in lap. Firefly is rapidly becoming a standard in robotics. Colorectal, bariatrics, gyn, urology are all asking for ICG. Full colour overlay is what will be the norm within twelve months on every system.

And as other robots are launching their ICG systems - it’s a must have.


No ICG - No party.

Surgeons will demand it - societies will mandate it - tenders will exclude you for not having it.


Feature poor and not integrated

Go and take a long look at the current and near term feature spec of the da Vinci 5 - that is the bar. Not the Si, not the X, not the Xi - but the da Vinci 5.

It’s here - it’s now and it’s setting the pace.


I have another full article on how you need to design and feature up your system - (Read it here.)

But if you don’t have integrated data, digital ecosystem, insufflation control (you don’t need the insufflator itself), energy control, a full instrument range, and all the goodies above - all well integrated into the console for on demand surgeon control.


Then you better have something so very different of an offering:

And no - a clone is no differentiated

No - cheap is not real (stop it !!!!)

No - large modular arms with Z rails are not differentiated - it’s a broken up Xi

No - Table mounting your robot is just moving the boom from above the bed to under the bed


Now…

Having a disposable robot - different

Having a micro robot - single port - different

Endolumenal robot - different

Advanced assisted laparoscopy - different


It’s all different - so you can get away with different feature sets - to some degree.


But going head to head with a da Vinci - get the same features - they are there for a reason - and Intuitive know a lot of things you don’t.



Summary

So if you are launching a system with no ICG, no advanced energy, no stapling, limited procedures where you are just defending your core business. You might have the wrong strategy.

If you are doing that into the USA - you definitely have the wrong strategy.

Now is maybe a good time to think about possible acquirers for your surgery businesses?

Because your robot is not going to succeed and it's not going to help you.


There is a right way to do this… but maybe that’s for another day (but do check out my blog post on what you could do.)

All I know is that there is defiantly a wrong way to do this. I’m sitting here  and watching a few slow train crashes happening because they are doing this the wrong way.



These are just opinions of the author and for educational purposes only.

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Ahmad Yahay
Ahmad Yahay
27 мар.
Оценка: 5 из 5 звезд.

Very informative

Лайк
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